510(k) K930468
K930468 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1993
- Date Received
- January 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type